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FDA 510(k)

URIC ACID-SL ASSAY CATALOGUE NO. 237-60

K-Number: K961586 · 1996-07-23

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1996-07-23
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID-SL ASSAY CATALOGUE NO. 237-60 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1996-07-23 under 510(k) number K961586. The device is classified under product code KNK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIC ACID-SL ASSAY CATALOGUE NO. 237-60?

URIC ACID-SL ASSAY CATALOGUE NO. 237-60 is a medical device that received FDA 510(k) clearance on 1996-07-23. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K961586.

When did URIC ACID-SL ASSAY CATALOGUE NO. 237-60 receive FDA 510(k) clearance?

URIC ACID-SL ASSAY CATALOGUE NO. 237-60 received FDA 510(k) clearance on 1996-07-23, under 510(k) number K961586.

Who is the listed applicant for URIC ACID-SL ASSAY CATALOGUE NO. 237-60?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URIC ACID-SL ASSAY CATALOGUE NO. 237-60?

The FDA product code for URIC ACID-SL ASSAY CATALOGUE NO. 237-60 is KNK.

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Other records listing Diagnostic Chemicals , Ltd. as applicant

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K070383ENZYMATIC CREATININE ASSAY (265 SERIES)K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91K051191DCL MICROALBUMIN ASSAY, MODEL 252-20

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Related Devices (Code: KNK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102568URIC ACID MODEL 3P39Abbott LaboratoriesK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98Olympus America, Inc.K040467VITALAB URIC ACID REAGENTClinical Data, Inc.K031044ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATORClinical Data, Inc.K022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDAWiener Laboratories Saic

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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